The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASEID CASEVERSION I F COD EVENT DT MFR DT INIT FDA DT FDA DT REPT COD AUTH NUM MFR NUM MFR SNDR LIT REF AGE AGE COD AGE GRP GNDR COD E SUB WT WT COD REPT DT TO MFR OCCP COD REPORTER COUNTRY OCCR COUNTRY
126274947 12627494 7 F 20160717 20160921 20160805 20160926 EXP KR-PFIZER INC-2016366831 PFIZER 56.00 YR M Y 0.00000 20160926 MD KR KR

Drug(s) used by person

Event ID CASEID DRUG SEQ ROLE COD DRUGNAME PROD AI VAL VBM ROUTE DOSE VBM CUM DOSE CHR CUM DOSE UNIT DECHAL RECHAL LOT NUM EXP DT NDA NUM DOSE AMT DOSE UNIT DOSE FORM DOSE FREQ
126274947 12627494 1 SS TREMELIMUMAB TREMELIMUMAB 1 Intravenous (not otherwise specified) 75 MG, CYCLIC (ONCE EVERY 4 WEEKS) 225 MG D 0 75 MG
126274947 12627494 2 SS TREMELIMUMAB TREMELIMUMAB 1 Intravenous (not otherwise specified) 75 MG, CYCLIC ( ONCE EVERY 4 WEEKS) 225 MG D 0 75 MG
126274947 12627494 3 SS TREMELIMUMAB TREMELIMUMAB 1 Intravenous (not otherwise specified) 75 MG, CYCLIC ( ONCE EVERY 4 WEEKS) 225 MG D 0 75 MG
126274947 12627494 4 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 5 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 6 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 7 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 8 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 9 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 10 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 11 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 12 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 13 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 14 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 15 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 16 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 17 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 18 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 19 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 20 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 21 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 22 SS FLUOROURACIL. FLUOROURACIL 1 Intravenous (not otherwise specified) 400 MG/M2 BOLUS ON DAY 1, 5FU 1200 MG/M2 IV OVER 24 H DAILY ON DAYS 1 AND 2 OF EACH CYCLE Y 0 400 MG/M**2 SOLUTION FOR INFUSION
126274947 12627494 23 PS OXALIPLATIN. OXALIPLATIN 1 Intravenous (not otherwise specified) 85 MG/M2 IV OVER 120 MIN ON DAY 1 Y 78813 85 MG/M**2
126274947 12627494 24 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous (not otherwise specified) 85 MG/M2 IV OVER 120 MIN ON DAY 1 Y 78813 85 MG/M**2
126274947 12627494 25 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous (not otherwise specified) 85 MG/M2 IV OVER 120 MIN ON DAY 1 Y 78813 85 MG/M**2
126274947 12627494 26 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous (not otherwise specified) 85 MG/M2 IV OVER 120 MIN ON DAY 1 Y 78813 85 MG/M**2
126274947 12627494 27 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous (not otherwise specified) 85 MG/M2 IV OVER 120 MIN ON DAY 1 Y 78813 85 MG/M**2
126274947 12627494 28 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous (not otherwise specified) 85 MG/M2 IV OVER 120 MIN ON DAY 1 Y 78813 85 MG/M**2
126274947 12627494 29 SS CALCIUM FOLINATE LEUCOVORIN CALCIUM 1 Intravenous (not otherwise specified) 400 MG/M2 IV OVER 120 MINUTES DAY 1 Y 8107 400 MG/M**2
126274947 12627494 30 SS CALCIUM FOLINATE LEUCOVORIN CALCIUM 1 Intravenous (not otherwise specified) 400 MG/M2 IV OVER 120 MINUTES DAY 1 Y 8107 400 MG/M**2
126274947 12627494 31 SS CALCIUM FOLINATE LEUCOVORIN CALCIUM 1 Intravenous (not otherwise specified) 400 MG/M2 IV OVER 120 MINUTES DAY 1 Y 8107 400 MG/M**2
126274947 12627494 32 SS CALCIUM FOLINATE LEUCOVORIN CALCIUM 1 Intravenous (not otherwise specified) 400 MG/M2 IV OVER 120 MINUTES DAY 1 Y 8107 400 MG/M**2
126274947 12627494 33 SS CALCIUM FOLINATE LEUCOVORIN CALCIUM 1 Intravenous (not otherwise specified) 400 MG/M2 IV OVER 120 MINUTES DAY 1 Y 8107 400 MG/M**2
126274947 12627494 34 SS CALCIUM FOLINATE LEUCOVORIN CALCIUM 1 Intravenous (not otherwise specified) 400 MG/M2 IV OVER 120 MINUTES DAY 1 Y 8107 400 MG/M**2
126274947 12627494 35 SS MEDI4736 DURVALUMAB 1 Intravenous (not otherwise specified) 1.5 G, CYCLIC (ONCE EVERY 4 WEEKS) 4.5 G D 0 1.5 G
126274947 12627494 36 SS MEDI4736 DURVALUMAB 1 Intravenous (not otherwise specified) 1.5 G, CYCLIC( ONCE EVERY 4 WEEKS) 4.5 G D 0 1.5 G
126274947 12627494 37 SS MEDI4736 DURVALUMAB 1 Intravenous (not otherwise specified) 1.5 G, CYCLIC (ONCE EVERY 4 WEEKS) 4.5 G D 0 1.5 G
126274947 12627494 38 SS CEFPODOXIME PROXETIL. CEFPODOXIME PROXETIL 1 Oral 200 MG, 2X/DAY 400 MG U 0 200 MG TABLET BID
126274947 12627494 39 C CURAN RANITIDINE HYDROCHLORIDE 1 Oral 75 MG, 2X/DAY 0 75 MG BID
126274947 12627494 40 C ALOXI PALONOSETRON HYDROCHLORIDE 1 Intravenous (not otherwise specified) 0.25MG AS REQUIRED 0 .25 MG
126274947 12627494 41 C DEXAMETHASONE. DEXAMETHASONE 1 Intravenous (not otherwise specified) 10.0MG AS REQUIRED 0 10 MG
126274947 12627494 42 C MACPERAN METOCLOPRAMIDE HYDROCHLORIDE 1 Intravenous (not otherwise specified) 30.0MG AS REQUIRED 0 30 MG
126274947 12627494 43 C MACPERAN METOCLOPRAMIDE HYDROCHLORIDE 1 Oral 5.0MG AS REQUIRED 0 5 MG
126274947 12627494 44 C PENIRAMIN 2 Intravenous (not otherwise specified) 2.0MG AS REQUIRED 0 2 MG
126274947 12627494 45 C MUCOPECT 2 Oral 30.0MG AS REQUIRED 0 30 MG
126274947 12627494 46 C DEXLANSOPRAZOLE DEXLANSOPRAZOLE 1 Oral 30.0MG AS REQUIRED 0 30 MG
126274947 12627494 47 C ALUMINIUM SUCRALFATE 2 Oral 15.0ML AS REQUIRED 0 15 ML
126274947 12627494 48 C MEGESTROL ACETATE. MEGESTROL ACETATE 1 Oral 10.0ML AS REQUIRED 0 10 ML
126274947 12627494 49 C APREPITANT. APREPITANT 1 Oral 125 MG, WEEKLY 0 125 MG /wk
126274947 12627494 50 C APREPITANT. APREPITANT 1 Oral 80 MG, WEEKLY 0 80 MG /wk
126274947 12627494 51 C GASTER FAMOTIDINE 1 Intravenous (not otherwise specified) 20 MG, 2X/DAY 240 MG 0 20 MG BID
126274947 12627494 52 C ARESTAL LOPERAMIDE OXIDE 1 Oral 1.0MG AS REQUIRED 0 1 MG
126274947 12627494 53 C SCOPOLAMINE /00008701/ SCOPOLAMINE 1 Oral 10.0MG AS REQUIRED 0 10 MG
126274947 12627494 54 C EPOCELIN 2 Intravenous (not otherwise specified) 2 G, 3X/DAY 42 G 0 2 G TID
126274947 12627494 55 C TRIDOL TRAMADOL HYDROCHLORIDE 1 Intravenous (not otherwise specified) 50 MG, 1X/DAY 50 MG 0 50 MG QD
126274947 12627494 56 C METHYSOL 2 Intravenous (not otherwise specified) 55 MG, 1X/DAY 275 MG 0 55 MG QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
126274947 12627494 1 Oesophageal adenocarcinoma
126274947 12627494 4 Oesophageal adenocarcinoma
126274947 12627494 23 Oesophageal adenocarcinoma
126274947 12627494 29 Oesophageal adenocarcinoma
126274947 12627494 35 Oesophageal adenocarcinoma
126274947 12627494 38 Infection prophylaxis
126274947 12627494 39 Abdominal pain upper
126274947 12627494 40 Premedication
126274947 12627494 41 Premedication
126274947 12627494 42 Premedication
126274947 12627494 44 Premedication
126274947 12627494 45 Nasopharyngitis
126274947 12627494 46 Abdominal pain upper
126274947 12627494 47 Abdominal pain upper
126274947 12627494 48 Decreased appetite
126274947 12627494 49 Premedication
126274947 12627494 51 Abdominal pain upper
126274947 12627494 52 Diarrhoea
126274947 12627494 53 Diarrhoea
126274947 12627494 54 Infection prophylaxis
126274947 12627494 55 Pyrexia
126274947 12627494 56 Diarrhoea

Outcome of event

Event ID CASEID OUTC COD
126274947 12627494 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
126274947 12627494 Colitis
126274947 12627494 Pyrexia

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
126274947 12627494 1 20160510 20160510 0
126274947 12627494 2 20160609 20160609 0
126274947 12627494 3 20160705 20160705 0
126274947 12627494 4 20160510 20160510 0
126274947 12627494 5 20160510 20160511 0
126274947 12627494 6 20160511 20160512 0
126274947 12627494 7 20160524 20160524 0
126274947 12627494 8 20160524 20160525 0
126274947 12627494 9 20160525 20160526 0
126274947 12627494 10 20160609 20160609 0
126274947 12627494 11 20160609 20160610 0
126274947 12627494 12 20160610 20160611 0
126274947 12627494 13 20160621 20160621 0
126274947 12627494 14 20160621 20160622 0
126274947 12627494 15 20160622 20160623 0
126274947 12627494 16 20160705 20160705 0
126274947 12627494 17 20160705 20160706 0
126274947 12627494 18 20160706 20160707 0
126274947 12627494 19 20160707 20160707 0
126274947 12627494 20 20160907 20160907 0
126274947 12627494 21 20160908 20160908 0
126274947 12627494 22 20160909 20160909 0
126274947 12627494 23 20160510 0
126274947 12627494 24 20160524 0
126274947 12627494 25 20160609 0
126274947 12627494 26 20160621 0
126274947 12627494 27 20160705 0
126274947 12627494 28 20160907 0
126274947 12627494 29 20160510 20160510 0
126274947 12627494 30 20160524 20160524 0
126274947 12627494 31 20160609 20160609 0
126274947 12627494 32 20160621 20160621 0
126274947 12627494 33 20160705 20160705 0
126274947 12627494 34 20160907 20160907 0
126274947 12627494 35 20160510 20160510 0
126274947 12627494 36 20160609 20160609 0
126274947 12627494 37 20160705 20160705 0
126274947 12627494 38 20160717 20160718 0
126274947 12627494 39 20160717 20160718 0
126274947 12627494 40 20160524 0
126274947 12627494 41 20160524 0
126274947 12627494 42 20160524 0
126274947 12627494 43 20160525 0
126274947 12627494 44 20160524 0
126274947 12627494 45 20160609 0
126274947 12627494 46 20160609 0
126274947 12627494 47 20160609 0
126274947 12627494 48 20160622 0
126274947 12627494 49 20160705 0
126274947 12627494 50 20160706 0
126274947 12627494 51 20160711 20160716 0
126274947 12627494 52 20160710 20160716 0
126274947 12627494 53 20160710 20160716 0
126274947 12627494 54 20160710 20160716 0
126274947 12627494 55 20160713 20160713 0
126274947 12627494 56 20160712 20160716 0

Execution Time: 0.010687112808228 seconds (ucode:5165199). Developed by: James D. Barger

 


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